Dr. Obama is in the house

Suzanne Ryan has a bum knee. If she doesn’t spend most of the day sitting down, she ends up coping with a lot of pain.

Her doctors say there are two options for the semi-retired elementary school teacher: Knee replacement surgery, using state-of-the-art plastic implants, or periodic injections to reduce inflammation and pain and improve joint flexibility.

When MassDevice first speaks with Ryan, in March, she’s unsure which offers the best chance of regaining mobility.

“I’m not sure which treatment I’ll choose,” Ryan says. “The device or the drugs.”

President Barack Obama wants to help her decide.

Comparative effectiveness research — studies to evaluate the relative efficacy medical treatments — is set for a major shot in the arm, with $1.1 billion set aside in the Obama administration’s recently approved American Recovery and Reinvestment Act.

The goal is to improve the quality of healthcare and, not incidentally, reduce the nation’s healthcare spend and its consequent strain on the U.S. economy: More than $2.2 trillion per year, or $7,421 per person, according to the Congressional Budget Office.

Not everyone sees the push for comparative effectiveness as a good thing.

Patient advocacy groups fear that the treatments deemed most effective — read “cheapest” — will be prescribed for every patient, regardless of their individual needs. Hospitals and patients alike are apprehensive about the adoption of low insurance reimbursement rates based on the findings.

And the medical device industry has quite a bit at stake as well: Devices often cost more than other treatments, or serve small, even marginal patient populations.

Industry advocates are all for determining the effectiveness of devices and other therapies, but have reservations about a system that rations care, says Wanda Moebius, vice president of policy communications for the Advanced Medical Technology Assn. (AdvaMed) in Washington, D.C.

“[The fear is that] it’s not about determining what works best,” Moebius says. “It’s about what happens when one treatment is better but costs more.”

Effective or cost-effective?

Medical devices are everywhere: More than 4 percent of Americans have at least one implanted medical device, and devices are used almost every time a patient is treated at a hospital.

That ubiquity, and the potential disparity in their effectiveness versus each other and treatments in other disciplines, has device makers casting a wary eye on the prospect of a nationwide comparative effectiveness blitz.

“How does the system handle a situation where a treatment works 30 percent better than the others, but costs 60 percent more?” Moebius asks.

The fear is that research outcomes will be linked to practice guidelines, meaning care prescribed based on the cost of a given treatment.

Executives at Covidien, the global medical devices giant headquartered in Mansfield, walk a cautious line when asked about their fears and hopes for the initiative.

“Most advocates of comparative effectiveness policies are focused on the patient first and believe that decisions should not be driven by cost,” writes Covidien vice president of global healthcare economics, policy and reimbursement Liesl Cooper in an email. “The focus should be clinical effectiveness, not cost effectiveness. … We share the industry’s support for clinical research. At the same time, we are mindful of the need for patients to have the best care possible.”

“I completely understand why a device industry executive would be concerned about cost effectiveness research,” says Dr. William Maisel, a cardiologist at Boston’s Beth Israel Deaconess Medical Center and founder and director of the Medical Device Safety Institute. “They don’t want cost to be a component of the decision regarding whether or not people use their device.”

But some product lines could benefit if, for example, research indicates they are more effective than medications, Maisel explains. It’s not difficult to imagine a boost in sales for a device placed on an “effective” list.

“If you have a good device that really helps people, you have a great chance of seeing an increase in sales,” Maisel says.

Conversely, for devices of marginal benefit there’s a good chance the research will result in a decline in sales.

“But that’s OK,” he says. “That’s what should happen.”

The British example

Several years ago, the U.K.’s National Health Service launched a comparative effectiveness board that links cost effectiveness with clinical effectiveness. The National Institute for Clinical Excellence combines economic evaluation and quality-adjusted “life year thresholds” to determine whether the cost of a given medical intervention can be justified — and paid for — by the government.

In other words, if the agency doesn’t think the number of quality years added to a patient’s life by a device or therapy are worth the cost, the United Kingdom won’t pay for it.

Scott Atlas, a senior fellow at the conservative Hoover Institution and a professor at Stanford University Medical Center, outlined the results of this policy in a February 2009 report to the National Center for Policy Analysis. 10 Surprising Facts about American Health Care (PDF) reveals several less-than satisfactory aspects of the health service — for example, breast cancer mortality in the U.K. is 88 percent higher than in the United States.

While the U.S. is far from nationalizing healthcare, there is great concern that the government will allow insurance providers to tie reimbursement rates to comparative effectiveness research outcomes.

According to Fran Miller, a professor of law, public health and healthcare management at Boston University and an expert in comparative health systems, patient advocacy groups are worried that government bean counters will bar idiosyncratic patients from access to the devices they need.

“People are worried that the idiosyncratic patient who doesn’t fit the norm will be closed out of the care they should have,” Miller says. “But that doesn’t go down well in our society — the minute a particular patient thinks they’re not getting a device they ‘need,’ people are going to be very upset.”

But Miller and Maisel agree that British-style rationing of care in the U.S. is very unlikely to occur, even in the face of a worsening economy.

“The medical community drives care in the direction of beneficial treatment,” Maisel says. “There is an unrealistic expectation of Americans in general that they are entitled to every therapy, regardless of how expensive it is,” he adds. “That just isn’t realistic. It wasn’t realistic before the economic downturn, and it isn’t now.”

“The bottom line is we can’t keep spending all this money on healthcare when the economy is tanking,” Miller adds.

Upsides and downsides

Comparative effectiveness research has been around for decades, but it’s never received so hearty a boost and so much public attention. On a smaller scale, it’s produced results for institutions and governments. Take Washington state, which used comparative effectiveness research to pare its annual Medicaid prescription drug bill by $40 million.

While the impact on the Massachusetts medical device industry remains to be seen, comparative effectiveness studies and clinical trials often compare device-based therapies with other treatments.

A study comparing several companies’ drug-eluting stents with drug therapy or other surgical interventions, for example, would be a high-stakes competition involving one of the Bay State’s most prominent medical technologies.

“This is life or death for a company,” Miller notes. “If yours isn’t on the list of approved medical devices — goodbye. Nobody goes out and buys devices out of pocket money.”

Although it could prove to be the death knell for some firms, the research might benefit the industry as a whole, indicating which devices invest in and develop.

Ultimately, however, the bottom line is improving healthcare outcomes. Rigorous and fair comparative effectiveness research improves the health of patients, by producing reliable data to improve clinical decision-making.

“I think there is an opportunity to improve patient care and improve patient cost. That’s why I think the stimulus bill is so important,” Maisel says, adding that research results could begin to emerge within 18 to 36 months.

“The device product life cycle is very short and I think, with the research money getting out there very quickly, we could see studies develop very soon,” he says.

Suzanne Ryan isn’t about to wait around for Obama’s initiative to determine which treatment will be best for her. She’s embarked on her own, miniature comparative effectiveness study.

Her doctors, believing she favored her bad knee to the point that her other knee started acting up, are taking a “watchful waiting” approach with more healthy knee, treating it with painkillers and keeping a close eye on its progress.

And she’s scheduled for replacement surgery on the bum knee later this month.

After that, she’ll be a walking example of comparative effectiveness research, able to evaluate each treatment’s effectiveness herself.